DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the application filed 7/17/2024. Claims 1-20 are pending. Claims 21-63 have been canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “receive a second data model being representative of a first class and a second class, the first data model configured to predict a first characteristic that is indicative of either of the first class or the second class…” It is unclear if applicant intends to further define the “first data model” (as written) or whether this second receiving step is intended to further define the “second data model.” (i.e. “receive a second data model being representative of a first class and a second class, the second data model configured to predict a first characteristic that is indicative of either of the first class or the second class…”
Claims 2-15 inherit the deficiencies of claim 1 through dependency, and are therefore also rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 1-20 are drawn to a systems..
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1-20 recite(s) a method and system which are drawn to mental processes, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance)
In particular, claims 1 and 16 recite:
determine a first correlation between the first data model and the second data model for the first class;
determine a second correlation between the first data model and the second data model for the second class;
utilize the first accuracy, the second accuracy, the first correlation, and the second correlation to determine a recommendation for fusing the first data model with the second data model; and
based on the recommendation being for or against fusion of the first data model with the second data model at least one of:
fuse the first data model with the second data model; or adjust an operation of the patient monitoring system.
As drafted, the language of claims 1 and 16 encompasses performance of the limitations(s) in the mind, but for the recitation of generic computer components.
The limitations of determining a first and second correlation; determining a recommendation for or against fusion, fusing the first with the second data model are steps that, under the broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “ a processor configured to,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the recitation of a processor configured to perform the steps, “determining” in the context of this claim encompasses the user reviewing the model and correlation data and manually calculating and deciding whether to fuse the models or not.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
As explained in MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). (emphasis added) As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978).
Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.
The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper").
Moreover, courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application.
Claims 1 and 16 additionally recite: receive a first data model being representative of a first class and a second class, the first data model configured to predict a first characteristic that is indicative of either of the first class or the second class; receive a second data model being representative of a first class and a second class, the first data model configured to predict a first characteristic that is indicative of either of the first class or the second class; determine or retrieve a first accuracy of the first data model; determine or retrieve a second accuracy of the second data model; determine a first correlation between the first data model and the second data model for the first class. The additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Claims 1 and 16 also recites: a processor device; a display in communication with the processor device. These additional elements is/are generic components that perform well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
Claim 1 additionally recites a first sensor in communication with the processor device (the first sensor being at least one of: an electrocardiogram sensor; a pressure sensor; a blood oxygenation sensor; an image sensor; an impedance sensor; or a physiological sensor); and a second sensor in communication with the processor device. However, these additional elements are generic components performing routine, well-known and conventional activities for a sensor (i.e. a sensor receiving data).
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “the computing devices 102, 104, and the server 106 can take any of a variety of forms, including traditional “computer” systems (desktop, laptop), mobile device (tablet or phone). In this way, the computing devices 102, 104 can include a processor device, memory, communication systems, a display, inputs (e.g., a mouse, a keyboard, touch screen or the like, to provide a user input, other sensors, such as physiological sensors, anatomical sensors, etc., communication systems, power sources, while the server 106 can include processor devices, memory, power sources (e.g., power supplies), communication systems, other inputs, and the like..” (par. 68 of the US PG-Pub)
The application also explains: “Some non-limiting examples of these systems and methods can include (or utilize) a device such as an automation device, a special purpose or general purpose computer including various computer hardware, software, firmware, and so on.” (see par. 247) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 1 and claim 16:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Claims 2-10 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 2-10 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 2-10 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 12-20 are dependent from Claim 11 and include(s) all the limitations of claim(s) 11. However, the additional limitations of the claims 12-20 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 12-20 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 10-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teixeira (US 20170079596 A1)
claim 1 Teixeira discloses a system for monitoring a plurality of patients ("The method and apparatus are optionally implemented in a rack system in a hospital intensive care unit, such as in connection, combination, and/or alongside other biomedical devices monitoring a patient''; para [0396]; para [0044]), the system comprising:
a processor device (para [0181]);
a display in communication with the processor device ("a processing engine within an executable program stored in a data processor, which is configured to receive digital data from one or more sensors and to output data to a display"; para [0181]);
a first sensor in communication with the processor device ("controller 110 controls a sensor 120"; para [0126]),
the first sensor being at least one of: an electrocardiogram sensor; a pressure sensor; a blood oxygenation sensor; an image sensor; an impedance sensor; or a physiological sensor ("ECG sensor data input"; fig 12A, para [0061]; para [0308]); and
a second sensor in communication with the processor device ("processing
engine ... configured to receive digital data from one or more sensors"; para [0181]), the second sensor being a physiological sensor ("a sensor 120 in the pulse oximeter apparatus 130"; para [0126]);
wherein the processor device is configured to:
receive, using the first sensor and the second sensor, a first data model being representative of a first class and a second class ("A first computational model used in the probabilistic updater 220 includes one or more state variables or state parameters ... state parameters include time, intensity, reflectance, and/or a pressure"; para [0136]), the first data model configured to predict a first characteristic that is
indicative of either of the first class or the second class ("A first computational model used in the probabilistic updater 220 includes one or more slate variables or state parameters, which correspond to the parameter being estimated by the state parameter updater 224 ... state parameters include time, intensity, reflectance, and/or a pressure."; para [0136]);
receive a second data model being representative of a first class and a second class ("computational model used in the probabilistic updater 220 includes one or more model parameters updated in the model parameter updater 226 .. .in the case of the hemodynamics monitoring apparatus, model parameters include: a time interval, a heart rate, a stroke volume and/or blood oxygen percentage"; para [0138]), the second data model configured to predict a first characteristic that is indicative of either of the first class or the second class ("the model compares shape of the ECG .. .to estimate, predict, or produce one or more of: an arrhythmia detection, an ischemia warning, and/or a heart attack warning"; para [0307]);
determine or retrieve a first accuracy of the first data model ("calculation of such a posterior state parameter PDF constitutes a noise filtering process and expectation values of the PDF optionally represent filtered sensor values and associated confidence intervals"; para [0136]);
determine or retrieve a second accuracy of the second data model ("the hemodynamics dynamic state-space model 805 ...form an estimate of a heart state parameter and/or a cardiovascular state parameter ... output of the probabilistic signal processor 200 optionally includes a measure of uncertainty, such as a confidence interval, a standard deviation, and/or a standard error; paras [0211], [0212]);
determine a first correlation between the first data model and the second data model for the first class ("A pulse oximeter and an electrocardiograph meter both provide information on the heart... in an electrocardiogram the left-ventricular stroke volume is related to the power spent during systolic contraction, which is, in turn, related to the electrical impulse delivered to that region of the heart. Indeed, the
R-wave amplitude is optionally correlated to contractility"; para [0339]);
determine a second correlation between the first data model and the second data model for the second class ("A pulse oximeter and an electrocardiograph meter both provide information on the heart ... As described, supra, the pulse oximeter also provides information on contractility, such as heart rate, stroke volume, cardiac output flow rate, and/or blood oxygen saturation information"; para [0339]);
utilize the first accuracy, the second accuracy, the first correlation, and the
second correlation to determine a recommendation for fusing the first data model with the second data model ("Detection performance is improved substantially relative to the best practitioners and current state-of-the-art algorithms by integrating a mathematical model of the heart with accurate and rigorous handling of probabilities"; para [0122]; "A pulse oximeter and an electrocardiograph meter both provide information on the heart. Hence, the pulse oximeter and the electrocardiograph meter provide overlapping information, which is optionally shared, such as between the hemodynamics dynamic state-space model 805 and the electrocardiogram dynamic state-space model
1105"; para [0339]; also paras [0136], [0212]); and
based on the recommendation being for or against fusion of the first data model with the second data model at least one of: fuse the first data model with the second data model; or adjust an operation of the patient monitoring system ("a fused model incorporating aspects of both the hemodynamics dynamic state-space model 805 and the electrocardiogram dynamic state-space model 1105 is created"; para [0339]).
claim 10 Teixeira discloses the system of claim 1, and Teixeira further discloses wherein the first class is indicative of a physiological condition of a subject ("the model is electrodynamic and contains state and model parameter variables corresponding to a
normal condition and an ischemic condition"; para [0266]), and the second class is indicative of not the physiological condition of the subject ("output from an instrument includes environmental information, such as temperature, pressure, vibration, and humidity''; para [0317]). and wherein the physiological condition is at least one of: a heart disorder; a blood disorder; a sleep disorder; a blood pressure disorder; an organ disorder; a metabolic disorder; a neoplastic disorder; a neurologic disorder; a psychological or psychiatric disorder; a traumatic injury; a hormonal disorder; a pulmonary disorder; an infectious disease; an immunologic disorder; a digestive disorder; a reaction to medication; or a toxin or toxicant exposure ("the pulse oximeter and electrocardiograph device state parameters 1830 optionally include one or more of: pulse oximeter related values of: a radial pressure (Pw);an aortic pressure"; paras [0349]-[0352]).
claim 11 Teixeira discloses the system of claim 10, and Teixeira further discloses wherein the physiological condition is a heart disorder, and the heart disorder is at least one of: an arrhythmia; atrial fibrillation; ventricular fibrillation; or tachycardia ("the output of the model processes low signal-to-noise ratio events to yield an early warning of any of the arrhythmia detection"; para [0106]).
claim 12 Teixeira discloses the system of claim 1, and Teixeira further discloses wherein the first class is indicative of a medical condition of a subject (para [0266]), and the second class is indicative of not the medical condition of the subject (para [0317]),
and wherein the medical condition is at least one of: a psychological condition; or a physiological condition {paras [0349]-[0352]).
claim 13 Teixeira discloses the system of claim 1, and Teixeira further disclose wherein the computing device is further configured to:
fuse together the first data model with the second data model based on the recommendation to create a fused data model (para [0339]);
receive an indication that an event has occurred ("Other data, such as user-input data, is optionally used in the output operation"; para [0132]);
based on the indication that the event has occurred, utilize at least one of the fused data model, the first data model, or the second data model ("The estimated parameters of the probabilistic sampler 230 are optionally used as a feedback to the
dynamic state-space model 210 or are used to estimate a biomedical parameter"; para [0132]).
claim 14 Teixeira discloses the system of claim 1, and Teixeira further discloses wherein the indication is a user input (para [0132]).
Claim 15 Teixeira teaches the system of claim 13, wherein the event is at least one of: a low battery signal; or an emergency indication (par. 306)
claim 16 Teixeira discloses a patient evaluation system being used across a hospital to evaluate, monitor, or determine a medical condition of multiple patients ("The method and apparatus are optionally implemented in a rack system in a hospital intensive care unit, such as in connection, combination, and/or alongside other biomedical devices monitoring a patient; para [0396]), the system comprising:
a processor device; a display in communication with the processor device (para (0181]);
wherein the processor device is configured to:
receive a plurality of data models, each data model being representative of a first class and a second class (paras [0136], [0138]), each of the data models being configured to predict a first characteristic that is indicative of either of the first class or the second class (paras [0136], [0307]);
select a plurality of pairs of data models, each pair of data models being of the plurality of data models ("the sub-models of the hemodynamics observation model 820 optionally share information"; para [0203]; "the sub-models of the electrocardiograph observation model 1120 optionally share information"; para [0272]); determine or retrieve, for each pair of data models, a first accuracy of one of the data models within the pair of data models and a second accuracy of the other data model within the data
models (paras [0136], [0212]);
determine or retrieve, for each pair of data models, a first accuracy of one of the data models within the pair of data models and a second accuracy of the other data model within the data models; ("calculation of such a posterior state parameter PDF constitutes a noise filtering process and expectation values of the PDF optionally represent filtered sensor values and associated confidence intervals"; para [0136]; "the hemodynamics dynamic state-space model 805 ...form an estimate of a heart state parameter and/or a cardiovascular state parameter ... output of the probabilistic signal processor 200 optionally includes a measure of uncertainty, such as a confidence interval, a standard deviation, and/or a standard error; paras [0211], [0212]))
determine or retrieve, for each pair of data models, a first correlation between the pair of data models for the first class, and a second correlation between the pair of data models for the second class; ("A pulse oximeter and an electrocardiograph meter both provide information on the heart... in an electrocardiogram the left-ventricular stroke volume is related to the power spent during systolic contraction, which is, in turn, related to the electrical impulse delivered to that region of the heart. Indeed, the R-wave amplitude is optionally correlated to contractility"; para [0339])
utilize, for each pair of data models, the first accuracy, the second accuracy, the first correlation, and the second correlation to determine a recommendation for fusing the pair of data models; and ("Detection performance is improved substantially relative to the best practitioners and current state-of-the-art algorithms by integrating a mathematical model of the heart with accurate and rigorous handling of probabilities"; para [0122]; "A pulse oximeter and an electrocardiograph meter both provide information on the heart. Hence, the pulse oximeter and the electrocardiograph meter provide overlapping information, which is optionally shared, such as between the hemodynamics dynamic state-space model 805 and the electrocardiogram dynamic state-space model 1105"; para [0339]; also paras [0136], [0212]
based on the recommendation for or against fusing the pair of data models at least one of: adjust an operation of the patient monitoring system, or a system in communication with the patient monitoring system, ("a fused model incorporating aspects of both the hemodynamics dynamic state-space model 805 and the electrocardiogram dynamic state-space model 1105 is created"; para [0339])
wherein adjust an operation includes at least one of: the processor device transmitting a notification to the system; (par. 132) or the processor device fusing one or more pairs of data models; (par. 339) the processor device notifying or activating the system being a paging system of a doctor;
generate a report that includes, for each pair of data models, the corresponding recommendation for or against fusing the pair of data models, and present, to the display, the report that includes the recommendation for or against fusing each pair of data models; store, for each pair of data models, the recommendation for or against fusing the pair of data models, in a computer readable memory. ("a fused model incorporating aspects of both the hemodynamics dynamic state-space model 805 and the electrocardiogram dynamic state-space model 1105 is created"; para [0339]).
Claims 17-20 The limitations of claims 17-20 are addressed by par. 71-72; par. 114-118
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira in view of Mazar (US 20120052794 A1).
Claims 2-4 Texiera teaches the system of claim 1 as explained, wherein adjust an operation of the patient monitoring system includes the processor device being further configured to prevent data acquisition from the first sensor or the second sensor, based on the recommendation against fusion of the first data model and the second data model for a period of time and/or wherein adjust an operation of the patient monitoring system includes the processor device being further configured to prevent further extraction of at least one of: the first variable from further data acquired by the first sensor; or the second variable from further data acquired by the second sensor.
Mazar teaches a system for adjusting operation of a patient monitoring device includes selectively preventing the recording of data from a medical device (i.e. sensor data acquisition) (par. 103; par. 109-110) and selectively blocking transfer of data sensor data (i.e. to prevent further extraction of at least one of: the first variable from further data acquired by the first sensor; or the second variable from further data acquired by the second sensor.) (See abstract; par. 101; Fig. 5) At the time of filing, ti would have been obvious to one of ordinary skill in the art to modify the system and method of Teixeira with the teaching of Mazar to adjust the functioning of a patient monitor to selectively block data recordation from sensors or data (variable) extraction. One would have been motivated to include these features to enhance patient privacy and control over their medical data (Mazar: par. 7; par. 99-100)
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira in view of Bartkowiak (US 2003/0235817 A1).
claims 5-6 Teixeira discloses the system of claim 1, and Teixeira further discloses wherein the recommendation is for fusion of the first data model and the second data model (paras [0122], [0136], [0339]). and wherein the processor device is further configured to, based on the recommendation for fusion of the first data model with the second data model: fuse the first data model and the second data model
together (para [0339]).
Teixeira does not disclose prevent, for a period of time, utilization of the first data model; and prevent, for another period of time, utilization of the second data model, and wherein the period of time and the another period of time includes any time that
the patient monitoring system is in operation, after implementation of the prevention of the respective utilizations. Bartkowiak discloses preventing, for a period of time, utilization of the first data model ("iterative estimation of the parameters is stopped"; para [0021 ]; "MOE models consist of a set of experts (i.e., mathematical models), that model conditional probabilistic processes"; para [0315]); and prevent, for another period of time. utilization of the second data model (paras [0021], [0315]), and wherein the period of time and the another period of time includes any time that the patient monitoring system is in operation, after implementation of the prevention of the respective utilizations ("obtaining a measured charge signal over time using an electrochemical sensor''; para [0024]; "The automatic nature of the systems also allow monitoring to continue even while the patient is sleeping or otherwise unable to test"; para [0110]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Teixeira invention to provide preventing utilization of the data models, as taught by Bartkowiak in order to provide a system that prevents the models from using statistically insignificant data.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teixeira in view of Averboch (US 2018/0075354 A1)
claims 7-9 Teixeira discloses the system of claim 1, and Teixeira further discloses the first accuracy (para [0136]) and the second accuracy (paras [0212], [0307]).
Teixeira does not disclose wherein the computing device is further configured to: combine the first correlation and the second correlation to determine a combined correlation; receive an accuracy threshold based on the combined correlation;
compare the first accuracy and the second accuracy to the accuracy threshold; and based on the comparison of the first accuracy and the second accuracy to the accuracy threshold determine the recommendation.
Averboch discloses combine the first correlation and the second correlation to determine a combined correlation (para [0043]); and providing a recommendation that the first and second data models should be combined, based on the combined correlation being below the threshold correlation ("if the model controller 110 finds that correlations between existing models and received data are less than a minimum confidence threshold, the model controller 110 recommends creating a new model"; para [0043]). It would have been obvious to one of ordinary skill in the art at the time of
the invention to modify the Teixeira invention to provide recommending combining models based on a combined correlation being below a threshold, as taught by Averboch, in order to provide appropriate recommendations based on the correlations (Averboch; para [0043]).
Although neither Teixeira nor Averboch specifically disclose comparing the first accuracy and the second accuracy to a threshold accuracy and based on the comparison of the first accuracy and the second accuracy to the accuracy threshold determine the recommendation, since Averboch discloses comparing the combined correlation with a threshold correlation (para [0043]), it would have been obvious to one
of ordinary skill in the art at the time of the invention, to that comparing the accuracy of the data models to a threshold would yield similar results as comparing the correlation of the models to a threshold.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Viswanath et al (Viswanath SE, Tiwari P, Lee G, Madabhushi A; Alzheimer’s Disease Neuroimaging Initiative. “Dimensionality reduction-based fusion approaches for imaging and non-imaging biomedical data: concepts, workflow, and use-cases.” BMC Med Imaging. 2017 Jan 5;17(1):2. doi: 10.1186/s12880-016-0172-6. PMID: 28056889; PMCID: PMC5217665.) discusses data fusion methods in processing biomedical data.
Lahat et al (D. Lahat, T. Adali and C. Jutten, "Multimodal Data Fusion: An Overview of Methods, Challenges, and Prospects," in Proceedings of the IEEE, vol. 103, no. 9, pp. 1449-1477, Sept. 2015, doi: 10.1109/JPROC.2015.2460697. ) discloses reasons for and issues associated with data fusion.
Wubbels et al (US 10599984 B1)- teaches a system in which training module 410 in FIG. 4 can ensemble multiple component machine learning models 800, 810 to obtain the ensembled machine learning model 850 by combining multiple outputs 820, 830 associated with the multiple component machine learning models 800, 810. In some embodiments, the multiple machine learning models 800, 810 can include ten machine learning models.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/Primary Examiner, Art Unit 3626